Penicillin G Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2014-08-15)
Oldest Current Product
1990-06-25
License(s)
NDA
RxNORM
INJECTION\PENICILLIN G
FDAOB
INJECTION\INJECTION\PENICILLIN G POTASSIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\PENICILLIN G POTASSIUM
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\PENICILLIN G

product(s) by strength(s)

50 ml penicillin g potassium 20000 unt/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381021NDABaxter Healthcare Corporation1990-06-25PENICILLIN G POTASSIUMINTRAVENOUSINJECTION, SOLUTIONNDA0506389e58122f-5c75-4905-a774-d3a4dae4ff8c

50 ml penicillin g potassium 40000 unt/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381023NDABaxter Healthcare Corporation1990-06-25PENICILLIN G POTASSIUMINTRAVENOUSINJECTION, SOLUTIONNDA0506389e58122f-5c75-4905-a774-d3a4dae4ff8c

50 ml penicillin g potassium 60000 unt/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381025NDABaxter Healthcare Corporation1990-06-25PENICILLIN G POTASSIUMINTRAVENOUSINJECTION, SOLUTIONNDA0506389e58122f-5c75-4905-a774-d3a4dae4ff8c

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA060074PENICILLIN G POTASSIUMTruePFIZER LABORATORIES DIV PFIZER INCANDA060074_003Penicillin G Injectable Solution
2ANDA060362PENICILLIN G POTASSIUMTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA060362_001, ANDA060362_002, ANDA060362_003, ANDA060362_004Penicillin G Injectable Solution
3ANDA060384PENICILLIN G POTASSIUMTrueELI LILLY AND COANDA060384_001, ANDA060384_002, ANDA060384_003, ANDA060384_004, ANDA060384_005Penicillin G Injectable Solution
4ANDA060601PENICILLIN G POTASSIUMTrueELI LILLY AND COANDA060601_001Penicillin G Injectable Solution
5ANDA060657PFIZERPENPFIZER LABORATORIES DIV PFIZER INCANDA060657_001, ANDA060657_002, ANDA060657_003Penicillin G Injectable Solution
6ANDA060806PENICILLIN G POTASSIUMTrueCONSOLIDATED PHARMACEUTICAL GROUP INCANDA060806_001, ANDA060806_002, ANDA060806_003, ANDA060806_004Penicillin G Injectable Solution
7ANDA062003PENICILLIN G POTASSIUMTruePARKE DAVIS DIV WARNER LAMBERT COANDA062003_001, ANDA062003_002Penicillin G Injectable Solution
8ANDA062991PENICILLIN G POTASSIUMTrueWATSON LABORATORIES INC1988-09-13ANDA062991_001, ANDA062991_002, ANDA062991_003, ANDA062991_004Penicillin G Injectable Solution
9ANDA065079PENICILLIN G POTASSIUMSANDOZ INC2002-08-30ANDA065079_001, ANDA065079_002, ANDA065079_003Penicillin G Injectable Solution
10ANDA065149PENICILLIN G POTASSIUMGC HANFORD MANUFACTURING CO2009-07-23ANDA065149_001, ANDA065149_002, ANDA065149_003Penicillin G Injectable Solution
11ANDA065448PENICILLIN G POTASSIUMISTITUTO BIOCHIMICO ITALIANO SPA2009-08-18ANDA065448_001, ANDA065448_002Penicillin G Injectable Solution
12NDA050638PENICILLIN G POTASSIUM IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1990-06-25NDA050638_001, NDA050638_002, NDA050638_003Penicillin G Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060074_003discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
2ANDA060362_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
3ANDA060362_002discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
4ANDA060362_003discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
5ANDA060362_004discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
6ANDA060384_001discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
7ANDA060384_002discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
8ANDA060384_003discontinuedPENICILLIN G POTASSIUM (500,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
9ANDA060384_004discontinuedPENICILLIN G POTASSIUM (200,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
10ANDA060384_005discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
11ANDA060601_001discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
12ANDA060657_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePFIZERPEN
13ANDA060657_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONTrueAPPFIZERPEN
14ANDA060657_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONTrueAPPFIZERPEN
15ANDA060806_001discontinuedPENICILLIN G POTASSIUM (500,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
16ANDA060806_002discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
17ANDA060806_003discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
18ANDA060806_004discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
19ANDA062003_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
20ANDA062003_002discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalsePENICILLIN G POTASSIUM
21ANDA062991_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
22ANDA062991_002discontinuedPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
23ANDA062991_003discontinuedPENICILLIN G POTASSIUM (10,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
24ANDA062991_004discontinuedPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalse1988-09-13PENICILLIN G POTASSIUM
25ANDA065079_001discontinuedPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse2002-08-30PENICILLIN G POTASSIUM
26ANDA065079_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2002-08-30PENICILLIN G POTASSIUM
27ANDA065079_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2002-08-30PENICILLIN G POTASSIUM
28ANDA065149_001RXPENICILLIN G POTASSIUM (1,000,000 UNITS/VIAL)INJECTIONFalse2009-07-23PENICILLIN G POTASSIUM
29ANDA065149_002RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2009-07-23PENICILLIN G POTASSIUM
30ANDA065149_003RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2009-07-23PENICILLIN G POTASSIUM
31ANDA065448_001RXPENICILLIN G POTASSIUM (5,000,000 UNITS/VIAL)INJECTIONFalseAP2009-08-18PENICILLIN G POTASSIUM
32ANDA065448_002RXPENICILLIN G POTASSIUM (20,000,000 UNITS/VIAL)INJECTIONFalseAP2009-08-18PENICILLIN G POTASSIUM
33NDA050638_001RXPENICILLIN G POTASSIUM (20,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
34NDA050638_002RXPENICILLIN G POTASSIUM (40,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
35NDA050638_003RXPENICILLIN G POTASSIUM (60,000 UNITS/ML)INJECTIONTrue1990-06-25PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19e58122f-5c75-4905-a774-d3a4dae4ff8c (view SPL)Penicillin G PotassiumInjection, USPIn PL 2040 Plastic ContainerFor Intravenous Use OnlyGALAXY Container (PL 2040 Plastic)prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-08-157003381021, 003381023, 003381025

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII